Comparison · NCT01625260-sae
0.06 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine vs 0.08 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. 0.06 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine vs 0.08 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine: serious adverse events. Trial comparisons, record NCT01625260-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01625260-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.333 | 0.121 | 0.646 | wilson | |
| Risk in group 2 | 0.333 | 0.0615 | 0.792 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.506 | 0.414 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1 | 0.158 | 6.35 | log | |
| Odds ratio, group 1 over group 2 | 1 | 0.0625 | 16 | log | |
| Number needed to harm | from the risk difference interval | the two groups' risks are equal |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | 0.06 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine | ALT-801 at 0.06 mg/kg with Gemcitabine at 1000 mg/m\^2~ALT-801: Intravenous infusion: 2 treatment courses and 1 maintenance course; on Day 3, 5, 8 and 15 of each course.~Gemcitabine: Intravenous infusion: 2 treatment courses and 1 maintenance course; on Day 1 and 8 of each course. | 3 | 9 | EG000 |
| Group 2 | 0.08 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine | ALT-801 at 0.08 mg/kg with Gemcitabine at 1000 mg/m\^2~ALT-801: Intravenous infusion: 2 treatment courses and 1 maintenance course; on Day 3, 5, 8 and 15 of each course.~Gemcitabine: Intravenous infusion: 2 treatment courses and 1 maintenance course; on Day 1 and 8 of each course. | 1 | 3 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- For AEs and SAEs: 30 days past treatment completion, up to 16 weeks. For all cause mortality: from start of treatment up to approximately 3 years.
Source ClinicalTrials.gov
Trial
- Title
- A Study of ALT-801 in Patients With Bacillus Calmette-Guerin (BCG) Failure Non-Muscle Invasive Bladder Cancer
- NCT number
- NCT01625260
- Phases
- PHASE1, PHASE2
- Conditions
- Non-muscle Invasive Bladder Cancer
- Interventions
- ALT-801, Gemcitabine
- Lead sponsor
- Altor BioScience
- Results first posted
- 2024-07-19
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01625260?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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